A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma (CheckMate 9DW)

January 17, 2024 updated by: Bristol-Myers Squibb

A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination With Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants With Advanced Hepatocellular Carcinoma

The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

732

Phase

  • Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Tucuman, Argentina, 4000
        • Local Institution - 0058
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, 1426
        • Local Institution - 0136
      • Caba, Buenos Aires, Argentina, C1090AAS
        • Local Institution - 0037
      • Pilar, Buenos Aires, Argentina, B1629AHJ
        • Local Institution - 0194
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Local Institution - 0282
  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • Local Institution - 0003
      • Liverpool, New South Wales, Australia, 1871
        • Local Institution - 0038
      • Westmead, New South Wales, Australia, 2145
        • Local Institution - 0002
    • Queensland
      • Birtinya, Queensland, Australia, 4560
        • Local Institution - 0004
      • Herston, Queensland, Australia, 4029
        • Local Institution - 0013
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution - 0009
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Local Institution - 0019
      • Fitzroy, Victoria, Australia, 3065
        • Local Institution - 0026
      • Melbourne, Victoria, Australia, 3004
        • Local Institution - 0001
      • St Albans, Victoria, Australia, 3021
        • Local Institution - 0020
  • Austria
      • Graz, Austria, 8036
        • Local Institution - 0188
      • Klagenfurt, Austria, 9020
        • Local Institution - 0065
      • St. Polten, Austria, 3100
        • Local Institution - 0114
      • Viena, Austria, 1090
        • Local Institution - 0186
    • Niederosterreich
      • Wiener Neustadt, Niederosterreich, Austria, 2700
        • Local Institution - 0057
  • Belgium
      • Federal District, Belgium, 72115700
        • Local Institution - 0008
      • Gent, Belgium, 9000
        • Local Institution - 0298
      • Gent, Belgium, 9000
        • Local Institution - 0124
      • Haine-Saint-Paul, Belgium, 7100
        • Local Institution - 0099
      • Leuven, Belgium, 3000
        • Local Institution - 0034
      • Leuven, Belgium, 3000
        • Local Institution - 0064
      • Liege, Belgium, 4000
        • Local Institution - 0104
  • Brazil
      • Rio de Janeiro, Brazil, 22793-080
        • Local Institution - 0015
      • Sao Paulo, Brazil, 01246-000
        • Local Institution - 0023
      • Sao Paulo, Brazil, 01323-001
        • Local Institution - 0022
      • Sao Paulo, Brazil, 04038-034
        • Local Institution - 0050
    • Bahia
      • Salvador, Bahia, Brazil, 41253190
        • Local Institution
      • Salvador, Bahia, Brazil, 41950-640
        • Local Institution - 0061
    • DF
      • Brasilia, DF, Brazil, 70200-730
        • Local Institution - 0181
    • Espirito Santo
      • Vitoria, Espirito Santo, Brazil, 29055-450
        • Local Institution - 0278
    • Parana
      • Curitiba, Parana, Brazil, 81520060
        • Local Institution - 0016
    • RIO Grande DO SUL
      • Pelotas, RIO Grande DO SUL, Brazil, 960400-10
        • Local Institution - 0060
    • Rio Grande Do Sul
      • Ijui, Rio Grande Do Sul, Brazil, 98700-000
        • Local Institution - 0279
    • SAO Paulo
      • Jau, SAO Paulo, Brazil, 17210-120
        • Local Institution - 0054
    • Sao Paulo
      • Sao Jose do Rio Preto, Sao Paulo, Brazil, 15090-000
        • Local Institution - 0280
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Local Institution - 0192
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4780000
        • Local Institution - 0296
    • Coquimbo
      • La Serena, Coquimbo, Chile, 1720430
        • Local Institution - 0094
    • Metropolitana
      • Santiago, Metropolitana, Chile, 7620002
        • Local Institution - 0024
      • Santiago, Metropolitana, Chile, 8380456
        • Local Institution - 0156
      • Santiago de Chile, Metropolitana, Chile
        • Local Institution - 0095
    • RM
      • Santiago, RM, Chile, 7630372
        • Local Institution - 0283
    • Valparaiso
      • Vina del Mar, Valparaiso, Chile, 2540402
        • Local Institution - 0216
      • Vina del Mar, Valparaiso, Chile, 2520598
        • Local Institution - 0012
  • China
      • Xi'an, China, 710126
        • Local Institution - 0307
    • Anhui
      • Hefei, Anhui, China, 230065
        • Local Institution - 0146
      • Hefei Shi, Anhui, China, 230022
        • Local Institution - 0120
    • Beijing
      • Beijing, Beijing, China, 100089
        • Local Institution - 0175
      • Beijing, Beijing, China, 100853
        • Local Institution - 0152
    • Fujian
      • Fuzhou, Fujian, China, 350002
        • Local Institution - 0151
      • Fuzhou City, Fujian, China, 350014
        • Local Institution - 0121
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Local Institution - 0125
      • Guangzhou, Guangdong, China, 510515
        • Local Institution - 0150
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Local Institution - 0135
    • Hunan
      • Changsha, Hunan, China, 410011
        • Local Institution - 0059
      • Changsha, Hunan, China, 410006
        • Local Institution - 0109
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Local Institution - 0130
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Local Institution - 0145
      • Nanchang, Jiangxi, China, 330019
        • Local Institution - 0149
    • Jilin
      • Changchun, Jilin, China, 130021
        • Local Institution - 0162
      • Changchun, Jilin, China, 130102
        • Local Institution - 0166
    • Liaoning
      • Dalian, Liaoning, China, 116023
        • Local Institution - 0131
      • Shenyang, Liaoning, China, 110004
        • Local Institution - 0123
      • Shenyang, Liaoning, China, 110117
        • Local Institution - 0132
    • Shaanxi
      • Xian, Shaanxi, China, 710061
        • Local Institution - 0147
    • Shan3xi
      • Xian, Shan3xi, China, 710038
        • Local Institution - 0133
    • Shandong
      • Qingdao, Shandong, China, 266000
        • Local Institution - 0153
    • Shanghai
      • Shanghai, Shanghai, China, 201315
        • Local Institution - 0134
    • Sichuan
      • Chongqing, Sichuan, China, 400030
        • Local Institution - 0179
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Local Institution - 0107
      • Hangzhou, Zhejiang, China, 310000
        • Local Institution - 0108
  • Czechia
      • Brno, Czechia, 60200
        • Local Institution
    • Prague
      • Praha, Prague, Czechia, 14059
        • Local Institution - 0274
  • France
      • Amiens, France, 80054
        • Local Institution - 0068
      • Caen, France, 14033
        • Local Institution - 0116
      • Clichy, France, 92110
        • Local Institution - 0069
      • Dijon, France, 21000
        • Local Institution - 0138
      • Grenoble Cedex 9, France, 38043
        • Local Institution - 0081
      • Lyon, France, 69004
        • Local Institution - 0070
      • Marseille, France, 13009
        • Local Institution
      • Montpellier, France, 34295
        • Local Institution - 0082
      • Nice, France, 6202
        • Local Institution - 0067
      • Pessac, France, 33604
        • Local Institution - 0025
      • Poitiers, France, 86021
        • Local Institution - 0137
      • Toulouse Cedex 9, France, 31059
        • Local Institution - 0042
      • Vandoeuvre les Nancy, France, 54500
        • Local Institution - 0071
      • Villejuif, France, 94800
        • Local Institution - 0051
  • Germany
      • Bonn, Germany, 53127
        • Local Institution - 0231
      • Essen, Germany, 45147
        • Local Institution - 0052
      • Freiburg, Germany, 79106
        • Local Institution - 0185
      • Hamburg, Germany, 20246
        • Local Institution - 0006
      • Hannover, Germany, 30625
        • Local Institution - 0102
      • Koeln, Germany, 50937
        • Local Institution - 0028
      • Leipzig, Germany, 04103
        • Local Institution - 0118
      • Mainz, Germany, 55131
        • Local Institution - 0031
      • Mannheim, Germany, 68167
        • Local Institution - 0056
      • Munchen, Germany, 81675
        • Local Institution
      • North Rhine-Westphalia, Germany, 45136
        • Local Institution - 0053
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Local Institution - 0005
  • Hong Kong
      • Hong Kong, Hong Kong
        • Local Institution - 0032
      • Hong Kong, Hong Kong, 999077
        • Local Institution - 0036
  • Italy
      • Candiolo, Italy, 10060
        • Local Institution - 0084
      • Milano, Italy, 20122
        • Local Institution - 0039
      • Novara, Italy, 28100
        • Local Institution - 0100
      • Padova, Italy, 35128
        • Local Institution - 0219
      • Parma, Italy, 43126
        • Local Institution - 0033
      • Roma, Italy, 00128
        • Local Institution - 0112
      • Rome, Italy, 00168
        • Local Institution - 0079
      • Siena, Italy, 53100
        • Local Institution - 0111
      • Vicenza, Italy, 36100
        • Local Institution - 0044
    • Forli-Cesena
      • Meldola, Forli-Cesena, Italy, 47014
        • Local Institution - 0110
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Local Institution - 0101
  • Japan
      • Fukuoka, Japan, 830-0011
        • Local Institution - 0178
      • Hiroshima, Japan, 7348551
        • Local Institution - 0177
      • Kanagawa, Japan, 213-8587
        • Local Institution - 0122
      • Saitama, Japan, 350-0495
        • Local Institution - 0258
    • Chiba
      • Chiba-shi, Chiba, Japan, 2608677
        • Local Institution - 0204
      • Kashiwa-shi, Chiba, Japan, 2778577
        • Local Institution - 0193
    • Ehime
      • Matsuyama, Ehime, Japan, 790-0024
        • Local Institution - 0203
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-0033
        • Local Institution - 0155
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8641
        • Local Institution - 0176
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Local Institution - 0262
      • Yokohama-Shi, Kanagawa, Japan, 232-0024
        • Local Institution - 0200
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 602-8566
        • Local Institution - 0189
    • Nara
      • Kashihara City, Nara, Japan, 634-8522
        • Local Institution - 0261
    • Osaka
      • Abeno-ku, Osaka, Japan, 5458586
        • Local Institution - 0263
      • Osakasayama, Osaka, Japan, 5898511
        • Local Institution - 0127
    • Saga
      • Saga Shi, Saga, Japan, 8408571
        • Local Institution - 0281
    • Shizuoka
      • Izunokuni-shi, Shizuoka, Japan, 4102295
        • Local Institution - 0259
    • Tokyo
      • Minato-ku, Tokyo, Japan, 1058470
        • Local Institution - 0128
      • Mitaka, Tokyo, Japan, 181-8611
        • Local Institution - 0201
      • Musashino-shi, Tokyo, Japan, 180-8610
        • Local Institution - 0199
  • Korea, Republic of
      • Busan, Korea, Republic of, 049241
        • Local Institution - 0142
      • Gyeonggi-do, Korea, Republic of, 010408
        • Local Institution - 0097
      • Gyeongsangnam-do, Korea, Republic of, 050612
        • Local Institution - 0098
      • Seoul, Korea, Republic of, 03722
        • Local Institution - 0141
      • Seoul, Korea, Republic of, 05505
        • Local Institution - 0140
      • Seoul, Korea, Republic of, 06351
        • Local Institution - 0139
      • Seoul, Korea, Republic of, 08308
        • Local Institution - 0167
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
        • Local Institution - 0143
    • Seoul
      • Jongno-gu, Seoul, Korea, Republic of, 03080
        • Local Institution - 0062
  • New Zealand
      • Auckland, New Zealand, 1142
        • Local Institution - 0047
  • Poland
      • Gdansk, Poland, 80219
        • Local Institution - 0148
      • Otwock, Poland, 05-400
        • Local Institution - 0049
      • Warszawa, Poland, 02-034
        • Local Institution - 0092
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
        • Local Institution - 0289
      • San Juan, Puerto Rico, 00927-4308
        • Local Institution - 0035
  • Romania
      • Bucharest, Romania, 022328
        • Local Institution - 0164
      • Cluj Napoca, Romania, 400015
        • Local Institution - 0165
      • Craiova, Romania, 200385
        • Local Institution
      • Timisoara, Romania, 300166
        • Local Institution - 0163
    • Dolj
      • Craiova, Dolj, Romania, 200542
        • Local Institution - 0103
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • Local Institution - 0029
      • Barnaul, Russian Federation, 656045
        • Local Institution - 0066
      • Chelyabinsk, Russian Federation, 454087
        • Local Institution - 0074
      • Moscow, Russian Federation, 115478
        • Local Institution - 0007
      • Pyatigorsk, Russian Federation, 357502
        • Local Institution - 0072
      • Saint-Petersburg, Russian Federation, 197758
        • Local Institution - 0075
      • Saint-Petersburg, Russian Federation, 198255
        • Local Institution - 0091
      • Sochi, Russian Federation, 354057
        • Local Institution - 0073
  • Singapore
      • Singapore, Singapore, 258499
        • Local Institution - 0017
      • Singapore, Singapore, 308442
        • Local Institution - 0174
      • Singapore, Singapore, 168583
        • Local Institution - 0048
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution - 0297
      • Barcelona, Spain, 08036
        • Local Institution - 0055
      • Barcelona, Spain, 08908
        • Local Institution - 0089
      • Cordoba, Spain, 14004
        • Local Institution - 0090
      • El Palmar, Spain, 30120
        • Local Institution - 0087
      • Madrid, Spain, 28007
        • Local Institution - 0041
      • Madrid, Spain, 28028
        • Local Institution - 0093
      • Madrid, Spain, 28035
        • Local Institution - 0290
      • Majadahonda, Spain, 28222
        • Local Institution - 0045
      • Pamplona, Spain, 31008
        • Local Institution - 0085
      • Santander, Spain, 39008
        • Local Institution - 0088
      • Zaragoza, Spain, 50009
        • Local Institution - 0040
  • Switzerland
      • Bern, Switzerland, 3010
        • Local Institution - 0063
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Local Institution - 0272
      • Kaohsiung, Taiwan, 83301
        • Local Institution - 0096
      • Taichung, Taiwan, 40447
        • Local Institution - 0105
      • Taichung, Taiwan, 40705
        • Local Institution - 0271
      • Tainan, Taiwan, 704
        • Local Institution - 0168
      • Tainan, Taiwan, 736
        • Local Institution - 0270
      • Taipei, Taiwan, 100
        • Local Institution - 0144
      • Taoyuan, Taiwan, 333
        • Local Institution - 0173
      • Tapei, Taiwan, 11217
        • Local Institution - 0078
  • United Kingdom
      • Christchurch, United Kingdom, BH23 2JX
        • Local Institution - 0286
      • Edinburgh, United Kingdom, EH4 2XU
        • Local Institution - 0160
      • London, United Kingdom, SE5 9RS
        • Local Institution - 0129
    • Greater London
      • London, Greater London, United Kingdom, W12 OHS
        • Local Institution - 0171
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XX
        • Local Institution - 0154
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Local Institution - 0292
    • California
      • Coronado, California, United States, 92118
        • Local Institution - 0288
      • Duarte, California, United States, 91010-3012
        • Local Institution - 0157
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Local Institution - 0077
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Local Institution - 0027
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Local Institution - 0190
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Local Institution
      • Detroit, Michigan, United States, 48202
        • Local Institution - 0018
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Local Institution - 0295
    • Ohio
      • Toledo, Ohio, United States, 43623
        • Local Institution - 0043
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Local Institution - 0284
    • Texas
      • Dallas, Texas, United States, 75203
        • Local Institution - 0304
      • Houston, Texas, United States, 77030
        • Local Institution - 0202
      • Lubbock, Texas, United States, 79410
        • Local Institution - 0046
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Local Institution - 0172

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must have a diagnosis of HCC based on histological confirmation
  • Participants must have an advanced HCC
  • Participants must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable previously untreated lesion
  • Child-Pugh score 5 or 6
  • Eastern Cooperative Oncology Group (ECOG) performance status(PS) 0 or 1

Exclusion Criteria:

  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  • Prior liver transplant
  • Episodes of hepatic encephalopathy (greater than or equal to [>=] Grade 2) within 12 months prior to randomization
  • Active brain metastases or leptomeningeal metastases

Other protocol-defined inclusion/exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nivolumab + Ipilimumab
Drug: Nivolumab
Participants will receive nivolumab as intravenous (IV) infusion.
Drug: Ipilimumab
Participants will receive ipilimumab as IV infusion.
Active Comparator: Sorafenib/lenvatinib
Drug: Sorafenib
Participants will receive sorafenib as oral tablets.
Drug: lenvatinib
Participants will receive lenvatinib as oral capsules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Up to 4 years
Up to 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of Response (DOR)
Time Frame: Up to 4 years
Up to 4 years
Objective Response Rate (ORR)
Time Frame: Up to 4 years
Up to 4 years
Time to Symptom Deterioration (TTSD)
Time Frame: Up to 4 years
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2019

Primary Completion (Estimated)

July 6, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

July 30, 2019

First Submitted That Met QC Criteria

July 30, 2019

First Posted (Actual)

July 31, 2019

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-9DW

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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